A Control- Labeled, Prospective, Randomized, Parallel Group, Multicentric, Phase III Clinical trial to evaluate Efficacy and Safety of a FDC of Lornoxicam 16mg SR + Thiocolchicoside 16mg SR Tablet OD Compared with FDC Lornoxicam 8mg + Thiocolchicoside 8mg Capsule BID in Patients Suffering from skeletal Muscular spasm of any etiology.

Alembic Ltd5 个研究点分布在 1 个国家目标入组 200 人开始时间: 2010年1月11日最近更新: 2013年3月20日

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 200
试验地点: 5
主要终点: Comparison percent of pain reduction within last 24 hours assessed using VAS at Day 7 in both treatment groups.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study will be conducted after obtaining written informed consent from the subjects. The subjects will undergo medical screening during pre-study visit (Visit 1). Screening will include complete clinical evaluation (medical history, physical examination, record of height, weight and vital signs). Female volunteers of child bearing capability will be subjected to a urine pregnancy test.Enrolled subjects will receive the medication for 1week (Visit 2). At visit 3 efficacy and ADR evaluation will be done. At visit 4 end of therapy efficacy, safety, tolerability and ADR monitoring will be done. Subjects are allowed to visit to investigator at any time point during the study.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Not Applicable

入排标准

年龄范围: 20.00 Year(s) 至 75.00 Year(s)（—）
性别: All

入选标准

•Non specific skeletal muscular spasm, with an acute episode Recent onset (<48 hours) defined by average pain and local immobility within the last 24 hours equal or more than grade 4 on the Visual Analogue Scale (VAS) Willing to give written informed consent.

排除标准

•Acute pain due to vertebral collapse or of no mechanical origin (suspected by history taking and physical examination), such as neoplasm, infection or inflammatory disorders Low back pain of diagnosis category 3 (low back pain radiating beyond the knee, with no neurologic signs) or 4 (low back pain radiating to a precise and entire leg dermatome, with or without neurologic signs), as defined by the International Paris Task Force on Back Pain History of inflammatory arthritis of large joints, History of seizure disorders, History of malignant tumor, Treatment with steroidal agents (including aspirin) during the two days prior to prospective inclusion, prolonged used of corticosteroids, Treatment with NSAIDs or muscle relaxant or opioid analgesics within 3 days of admission, Psychiatric or mental diseases Immune Compromised HIV.
•Inclusion in another study in the past six months or previous inclusion in this study, History of alcohol, drugs or narcotics abuse Recent history of violent trauma, Constant progressive, non mechanical pain (no relief with bed rest), Thoracic pain, Patient systemically unwell, Unexplained weight loss, Widespread neurological symptoms (including Cauda equine syndrome), Structural deformity Fever, Clinical significant renal dysfunction defined by Creatinine > 1.5 UNL, Clinically significant hepatic dysfunction defined by: Total Bilirubin > 2 UNL SGOT (AST) > 1.5 UNL SGPT (ALT) > 1.5 UNL Patients who have received other therapy (physiotherapy, physical manipulations, invasive intervention, acupuncture therapy) within the last 48 hours.
•Pregnancy, breast feeding or women of childbearing potential not using efficient contraception.

结局指标

主要结局

Comparison percent of pain reduction within last 24 hours assessed using VAS at Day 7 in both treatment groups.

时间窗: Baseline and completion of treatment

次要结局

Average reduction in mean pain score within last 24 hours assessed using VAS by Investigator and Subject at day 14 i.e. completion of protocol treatment in both treatment groups.(Baseline and completion of treatment)

研究者

发起方

Alembic Ltd

申办方类型

Pharmaceutical industry-Indian

研究点 (5)

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